1. Field of the Invention
The present invention relates to products, compositions, methods and apparatus for identification of cancers and pre-cancerous cellular changes. In another aspect, the present invention relates to products, compositions, methods and apparatus for identification of breast cancers or pre-cancerous cellular changes in breast tissues. In even another aspect, the present invention relates to products, compositions, methods and apparatus for treatment of cancers and pre-cancerous cellular changes. In still another aspect, the present invention relates to products, compositions, methods and apparatus for treatment of breast cancer and pre-cancerous cellular changes in breast tissues.
2. Description of the Related Art
Breast cancer is the most common form of cancer in women in the United States. It is estimated that in the year 2000, 182,800 new cases of female invasive breast cancer will be diagnosed, and 40,800 women will die from the disease. All women are at risk for breast cancer, with this risk increasing as a woman ages. Women are generally considered to be at increased risk for developing breast cancer if they have one or more of the following risk factors: a) a family history of breast cancer, b) a previous diagnosis of a malignant breast tumor or other gynecological cancers, c) hormonal factors, or d) not having had any children or having the first child later in their child bearing years. Even so, the majority of all breast cancers occur in women who apparently do not have identifiable risk factors.
Breast cancer cannot currently be prevented. But detecting and treating it at an early stage, when the tumor is small and has not spread beyond the breast, can increase the chances of survival significantly. However, not all breast cancers are currently detected at this early stage. Therefore, screening for breast cancer has become a critical aspect in the overall management of this disease.
The techniques currently used to screen for breast cancer and other breast conditions include monthly breast self examination, mammography, and clinical breast examination. Also, genetic testing can be performed for BRCA1 and BRCA2 genes in women who have a strong family history of breast cancer, since these genes are associated with approximately 5 to 10 percent of breast cancer cases. In spite of this genetic knowledge, the genetic changes involved in the vast majority of breast cancers remains largely undetermined.
Human papillomaviruses (HPV) are strongly linked to cervical and other cancers. Cervical cancer (CX CA) is the second most prevalent female cancer world-wide. HPV 16 DNA is present in 65% of CX CAs, and with the other HPV types, more than 90% of CX CAs contain HPV DNA. The E6 and E7 genes of HPV 16s can cause contact-inhibited cells to lose this phenotype. Furthermore, E6 and E7 interact with the cellular anti-oncogenes RB105 and p53, respectively, leading to their inactivation. Thus, it is widely regarded that HPV-16 is a central etiologic agent and risk factor in the development of cervical/genital cancer. The E7 protein, and possibly E6 as well, also function as transcriptional transactivators of heterologous genes. HPVs have also been found in oral, penile, and vulvar cancer.
It appears that whatever tissue site HPVs are known to infect, they cause pathology. Usually the pathology is limited to a tissue hyperplasia or papilloma. However, there is a significant risk that this higher than normal active cell growth may become an outright malignancy.
However, as recent studies have indicated, the relationship between HPV infection and breast cancer is controversial.
Hennig et al. (1999) have reported that of women studied in Norway having concomitant advanced genital HPV infection (cervical intraepithelial neoplasia III, “CIN III”) in addition to breast cancer, 46% of the breast cancers also contained HPV 16. However, of the control study of eight patients having breast cancer diagnosed before the CIN III lesions, none had HPV positive breast carcinomas. Additionally no cases in the study were positive for HPV 11, 18 or 33.
Yu et al. (1999) report that HPV 33 is associated in pre-malignant and malignant breast lesions in Chinese and Japanese populations, and further suggest that HPV 16 and HPV 18 are not involved in breast hyperplastic lesion, especially breast cancer.
In spite of the advancements in the art, there is a need in the art for improved compositions, methods and products for screening a patient for cancer and/or pre-cancerous cellular changes.
There is another need in the art for improved compositions, products and methods for screening a patient for breast cancer and/or pre-cancerous cellular changes in the breast.
There is even another need in the art for improved compositions, products and methods for treating a patient afflicted with a cancer in any stage of development.
There is still another need in the art for improved compositions, products and methods for treating a patient afflicted with breast cancer and/or a pre-cancerous cellular changes in the breast in any stage of development.
These and other needs in the art will become apparent to those of skill in the art upon review of this specification, including its drawings, claims and appendix.